Efficacy and Safety of Short-term High-dose Vitamin D Supplementation Combined With Standard Behavioral Therapy for the Treatment of Dry Overactive Bladder in Children: a Prospective, Randomized Controlled, Multicentre Clinical Study

The aim of this study is to give children with dry OAB: (1) Standard behavioral therapy combined with classical anticholinergic drugs (Solinaxine), or (2) standard behavioral therapy combined with short-term high-dose exogenous vitamin D supplementation are used to compare the outcomes of lower urinary tract symptoms in children with dry OAB during follow-up. To provide more robust supporting evidence for the broader promotion of short-term high-dose exogenous vitamin D supplements in combination with standard behavioral therapy as an effective treatment for dry OAB treatment in children.

Start Date01 Dec 2024

Sponsor / Collaborator

Children’S Hospital Of Chongqing Medical University

[+2]

CTRI/2024/09/073950 / Not yet recruitingNot ApplicableIIT

Effect of oral flavoxate on postoperative catheter related bladder dysfunction in adult males undergoing transurethral resection of bladder tumors- A randomized controlled trial vs solifenacin and placebo - Nil

Start Date17 Sep 2024

Sponsor / Collaborator-

NCT06551246 / RecruitingPhase 3IIT

Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children with Overactive Bladder and Daytime Urinary Incontinence (BeDry)

The primary objective is to evaluate if (1) combination therapy of solifenacin and mirabegron in low doses is superior to monotherapy of solifenacin in high dose and if (2) combination therapy of mirabegron and solifenacin in low doses is superior to monotherapy of mirabegron in high dose in treatment of daytime urinary incontinence among children aged 5 to 14 years who are none complete responders to respectively monotherapy of solifenacin in low dose or monotherapy of mirabegron in low dose.
In total, 236 children diagnosed with daytime urinary incontinence will be randomized 1:1:1:1 to one of four treatment groups. Total pharmacological treatment period will be 18 weeks.

Start Date27 Jun 2024

Sponsor / Collaborator

University of Aarhus

100 Clinical Results associated with Solifenacin Succinate

100 Translational Medicine associated with Solifenacin Succinate

100 Patents (Medical) associated with Solifenacin Succinate

147

Literatures (Medical) associated with Solifenacin Succinate

01 Oct 2024·Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy

Diaryl pyrrolone fluorescent probing strategy for Mirabegron determination through condensation with ninhydrin and phenylacetaldehyde: Application to dosage forms, human urine and plasma

Article

Author: Abdelshakour, Mohamed A ; Badr El-Din, Khalid M ; Ahmed, Ahmed S ; Oraby, Mohamed ; Derayea, Sayed M

Mirabegron (MRB) is a β₃-adrenoceptor agonist used for managing overactive bladder syndrome. A cost-effective, environmentally friendly, and highly sensitive spectrofluorimetric method was suggested to serve the purpose of quantifying MRB in its pure state, pharmaceutical tablets, spiked human plasma and urine, and testing content uniformity. In the present study, ninhydrin and phenylacetaldehyde react with the amino group moiety of MRB in Teorell-Stenhagen buffer (pH 7.5) to generate a strongly fluorescent diaryl pyrrolone compound that emits fluorescence at a wavelength of 477 nm upon excitation at 385 nm. The obtained calibration curve showed a linear relationship with a high correlation coefficient (r = 0.9997) in the concentration range of 0.25 to 5.0 µg mL^-1. Limits of detection (LOD) and quantitation (LOQ) were 0.082 and 0.248 µg mL^-1 respectively. The procedure was verified in accordance with the ICH guidelines. The suggested approach could be utilized for the selective analysis of MRB in its pharmaceuticals, either containing a single drug or co-formulated with solifenacin succinate. The greenness of the suggested method was confirmed using different green analytical metrics.

01 Oct 2024·Heliyon

Disproportionality analysis of drug-induced dry mouth using data from the United States food and drug administration adverse event reporting system database

Article

Author: Xu, Dan ; Wu, Meng ; Zhu, Hong

BackgroundDrug-induced dry mouth is an adverse reaction that can significantly affect the quality of life and mental state of patients. In this study, we aimed to identify the most common drugs associated with dry mouth using data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.MethodsWe accessed data from the FAERS database between the first quarter of 2004 and the first quarter of 2024. The Medical Dictionary for Regulatory Activities was used to identify reports of dry mouth, and disproportionality analyses (reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker) were performed to examine the risk signals for dry mouth and its causative drugs.ResultsA total of 75,899 adverse event reports were related to dry mouth. Tiotropium bromide monohydrate (2080 cases) was associated with the majority of dry mouth cases. Disproportionality analysis revealed that the top five drugs with the highest reporting odds ratio (ROR) were darifenacin, solifenacin succinate, fesoterodine fumarate, tolterodine tartrate, and niraparib. Moreover, eight of the top 19 drugs that caused dry mouth were not identified as having major side effects in the package inserts.ConclusionTiotropium bromide monohydrate was the most frequently reported drug for dry mouth, whereas darifenacin had the highest ROR. Collectively, our findings emphasize the necessity for improved recognition and management of drug-induced dry mouth, particularly for medications not adequately flagged for this side effect in their labels.

01 Sep 2024·BMJ Open

Electroacupuncture versus solifenacin succinate for female overactive bladder: study protocol for a multicentre, randomised, controlled, double-dummy, non-inferiority trial

Article

Author: Hu, Junwei ; Chen, Yue-Lai ; Li, Xu ; Chen, Bingli ; Huai, Yisheng ; Yin, Ping ; Hou, Wenguang ; Ming, Shuren ; Li, Juanjuan ; Chow, Sandra Teresa ; Fan, Qian ; Liu, Lumin

IntroductionOveractive bladder (OAB) affects approximately 500 million people worldwide, with a higher prevalence in women than in men, significantly impacting the quality of life of female patients. Treatment options for OAB are currently limited. Previous research has proposed that electroacupuncture could be a viable treatment for OAB in women, but there is a lack of high-quality clinical evidence. This study aims to evaluate the effectiveness of electroacupuncture as a safe and efficient non-pharmacological treatment for female OAB by comparing it with solifenacin succinate.Methods and analysisThis study is a multicentre, single-blind, double-dummy randomised controlled non-inferiority clinical trial involving 204 eligible female participants with OAB. Participants will be randomly assigned in a 1:1 ratio to either the electroacupuncture group (receiving electroacupuncture and placebo) or the solifenacin succinate group (receiving sham electroacupuncture and solifenacin succinate). Each participant will undergo 12 sessions of electroacupuncture (or sham electroacupuncture) treatment and solifenacin succinate (or placebo) treatment over a 4-week period. The primary outcome measure will be the percentage change in the number of micturition episodes every 24 hours at week 4 compared with baseline. Secondary outcomes will include a percentage reduction in the number of micturition episodes every 24 hours at 2th, 8th and 16th weeks of the trial, Overactive Bladder Symptom Score, number of urinary incontinence and urgency episodes every 24 hours based on a 3-day voiding diary, OAB Questionnaire, Generalised Anxiety Disorder Scale-7, King’s Health Questionnaire and Participant Self-evaluation of Therapeutic Effects. Adverse events will be monitored throughout the study. Efficacy analyses will be conducted on both the intention-to-treat population and the per-protocol set population.Ethics and disseminationEthical approval has been obtained from the Medical Ethics Committee of Longhua Hospital Shanghai University of Traditional Chinese Medicine (approval number: 2022LCSY097). Each participant will sign a written informed consent before randomisation. The results of this study will be published in a peer-reviewed journal.Trial registration number NCT05798403.

News (Medical) associated with Solifenacin Succinate

29 Jun 2022

·www.prnewswire.com

Interstitial Cystitis Drugs Market Recorded 4.81% Y-O-Y Growth Rate in 2021| Evolving Opportunities with Perrigo Co. Plc & Pfizer Inc | Technavio

NEW YORK, June 29, 2022 /PRNewswire/ -- The Interstitial Cystitis Drugs Market report provides a detailed analysis of the competitive scenario, the pre-and post-COVID-19 impact on businesses, and the market growth across various regions. The interstitial cystitis drugs market size is expected to increase by USD 283.95 million, at a CAGR of 5.06% from 2020 to 2025. Technavio categorizes the interstitial cystitis drugs market as a part of the global pharmaceuticals market within the overall healthcare industry. Our research report has extensively covered external factors influencing the parent market growth potential in the coming years, which will determine the levels of growth of the interstitial cystitis drugs market during the forecast period. Technavio has announced its latest market research report titled Interstitial Cystitis Drugs Market by Type and Geography - Forecast and Analysis 2021-2025 For more highlights on the parent market analysis - Request a sample now! Market Dynamics Drivers: The high prevalence of interstitial cystitis is notably driving the interstitial cystitis drugs market growth Trends: Increasing awareness of interstitial cystitis is the key market trend driving the interstitial cystitis drugs market growth. Challenges: The major challenge impeding the interstitial cystitis drugs market growth is the lack of approved drugs. For detailed highlights on the market dynamics - Click Now! Segmentation Analysis By Type, the market is classified into oral therapy and intravesical therapy. The interstitial cystitis drugs market share growth by the oral therapy segment will be significant for revenue generation. Pentosan polysulfate sodium (ELMIRON) is the only approved oral medication to repair the lining of the bladder in people with interstitial cystitis (IC). ELMIRON builds and restores the protective coating of the bladder tissue. There are many off-label oral drugs in the interstitial cystitis drugs market that can reduce the signs and symptoms of the disease facilitating the growth of the segment during the forecast period. By Geography, the market is classified as North America, Europe, Asia, and ROW. 36% of the market's growth will originate from North America during the forecast period. The US is a key market for interstitial cystitis drugs in North America. However, the market growth rate in this region will be slower than the growth of the market in Asia and Europe. The increasing cases of interstitial cystitis and a rise in research funding will facilitate the interstitial cystitis drugs market growth in North America over the forecast period. Company Profiles The interstitial cystitis drugs market is fragmented and the vendors are deploying various organic and inorganic growth strategies to compete in the market. The interstitial cystitis drugs market report provides complete insights on key vendors including Astellas Pharma Inc., Bayer AG, Johnson and Johnson Inc., Novartis AG, Perrigo Co. Plc, Pfizer Inc., Seikagaku Corp., Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., and Viatris Inc. Key Offerings: Perrigo Co. Plc - The company offers pain and sleep aids such as Ibuprofen. Pfizer Inc. - The company offers an interstitial cystitis drug named Toviaz. Seikagaku Corp. - The company is developing the interstitial cystitis and bladder pain syndrome drug SI-722. Sun Pharmaceutical Industries Ltd. - The company offers interstitial cystitis drugs such as Cystopen capsules Teva Pharmaceutical Industries Ltd. The company offers interstitial cystitis drugs such as VESIcare (solifenacin succinate) Tablets. To know about all major vendor offerings - Grab a sample now! Get ready to achieve excellent business outcomes from this exclusive Interstitial Cystitis Drugs Market report by Technavio. The report will include highlights of the overall market which includes frequently asked questions such as - What are historical revenue figures and estimated revenue figures as well as CAGR during the forecast timeframe? What is the current trend taking place in the market space? Which are business tactics that will influence competitive scenarios along with defining the growth potential of the market? What are market drivers, restraints, and challenges impacting demand & growth of the market? Which regions & segments will garner massive revenue and emerge as market leaders in upcoming years? The competitive scenario provided in the Interstitial Cystitis Drugs Market report analyzes, evaluates, and positions companies based on various performance indicators. Some of the factors considered for this analysis include the financial performance of companies over the past few years, growth strategies, product innovations, new product launches, investments, growth in market share, etc. Don't wait, Make a strategic approach & boost your business goals with our Interstitial Cystitis Drugs Market Forecast Report - Buy Now! Related Reports: The uveitis drugs market share is expected to increase to USD 269.65 million from 2021 to 2026, and the market's growth momentum will accelerate at a CAGR of 5.9%. The vitiligo therapeutics market share is expected to increase to USD 341.35 million from 2021 to 2026, and the market's growth momentum will accelerate at a CAGR of 4.5%. Table of Content 1 Executive Summary 2 Market Landscape 2.1 Market ecosystem Exhibit 01: Parent market Exhibit 02: Market characteristics 2.2 Value chain analysis Exhibit 03: Value chain analysis: Pharmaceuticals 3 Market Sizing 3.1 Market definition Exhibit 04: Offerings of vendors included in the market definition 3.2 Market segment analysis Exhibit 05: Market segments 3.3 Market size 2020 3.4 Market outlook: Forecast for 2020 - 2025 Exhibit 06: Global - Market size and forecast 2020 - 2025 ($ million) Exhibit 07: Global market: Year-over-year growth 2020 - 2025 (%) 4 Five Forces Analysis 4.1 Five forces summary Exhibit 08: Five forces analysis 2020 & 2025 4.2 Bargaining power of buyers Exhibit 09: Bargaining power of buyers 4.3 Bargaining power of suppliers Exhibit 10: Bargaining power of suppliers 4.4 Threat of new entrants Exhibit 11: Threat of new entrants 4.5 Threat of substitutes Exhibit 12: Threat of substitutes 4.6 Threat of rivalry Exhibit 13: Threat of rivalry 4.7 Market condition Exhibit 14: Market condition - Five forces 2020 5 Market Segmentation by Type 5.1 Market segments Exhibit 15: Type - Market share 2020-2025 (%) 5.2 Comparison by Type Exhibit 16: Comparison by Type 5.3 Oral therapy - Market size and forecast 2020-2025 Exhibit 17: Oral therapy - Market size and forecast 2020-2025 ($ million) Exhibit 18: Oral therapy - Year-over-year growth 2020-2025 (%) 5.4 Intravesical therapy - Market size and forecast 2020-2025 Exhibit 19: Intravesical therapy - Market size and forecast 2020-2025 ($ million) Exhibit 20: Intravesical therapy - Year-over-year growth 2020-2025 (%) 5.5 Market opportunity by Type Exhibit 21: Market opportunity by Type 6 Customer landscape 7 Geographic Landscape 7.1 Geographic segmentation Exhibit 23: Market share by geography 2020-2025 (%) 7.2 Geographic comparison Exhibit 24: Geographic comparison 7.3 North America - Market size and forecast 2020-2025 Exhibit 25: North America - Market size and forecast 2020-2025 ($ million) Exhibit 26: North America - Year-over-year growth 2020-2025 (%) 7.4 Europe - Market size and forecast 2020-2025 Exhibit 27: Europe - Market size and forecast 2020-2025 ($ million) Exhibit 28: Europe - Year-over-year growth 2020-2025 (%) 7.5 Asia - Market size and forecast 2020-2025 Exhibit 29: Asia - Market size and forecast 2020-2025 ($ million) Exhibit 30: Asia - Year-over-year growth 2020-2025 (%) 7.6 ROW - Market size and forecast 2020-2025 Exhibit 31: ROW - Market size and forecast 2020-2025 ($ million) Exhibit 32: ROW - Year-over-year growth 2020-2025 (%) 7.7 Key leading countries Exhibit 33: Key leading countries 7.8 Market opportunity by geography Exhibit 34: Market opportunity by geography ($ million) 8 Drivers, Challenges, and Trends 8.1 Market drivers 8.2 Market challenges Exhibit 35: Impact of drivers and challenges 8.3 Market trends 9 Vendor Landscape 9.1 Overview 9.2 Vendor landscape Exhibit 36: Vendor landscape 9.3 Landscape disruption Exhibit 37: Landscape disruption Exhibit 38: Industry risks 10 Vendor Analysis 10.1 Vendors covered Exhibit 39: Vendors covered 10.2 Market positioning of vendors Exhibit 40: Market positioning of vendors 10.3 Astellas Pharma Inc. Exhibit 41: Astellas Pharma Inc. - Overview Exhibit 42: Astellas Pharma Inc. - Product and service Exhibit 43: Astellas Pharma Inc. - Key news Exhibit 44: Astellas Pharma Inc. - Key offerings 10.4 Bayer AG Exhibit 45: Bayer AG - Overview Exhibit 46: Bayer AG - Business segments Exhibit 47: Bayer AG - Key news Exhibit 48: Bayer AG - Key offerings Exhibit 49: Bayer AG - Segment focus 10.5 Johnson and Johnson Inc. Exhibit 50: Johnson and Johnson Inc. - Overview Exhibit 51: Johnson and Johnson Inc. - Business segments Exhibit 52: Johnson and Johnson Inc. - Key news Exhibit 53: Johnson and Johnson Inc. - Key offerings Exhibit 54: Johnson and Johnson Inc. - Segment focus 10.6 Novartis AG Exhibit 55: Novartis AG - Overview Exhibit 56: Novartis AG - Business segments Exhibit 57: Novartis AG - Key news Exhibit 58: Novartis AG - Key offerings Exhibit 59: Novartis AG - Segment focus 10.7 Perrigo Co. Plc Exhibit 60: Perrigo Co. Plc - Overview Exhibit 61: Perrigo Co. Plc - Business segments Exhibit 62: Perrigo Co. Plc - Key news Exhibit 63: Perrigo Co. Plc - Key offerings Exhibit 64: Perrigo Co. Plc - Segment focus 10.8 Pfizer Inc. 10.9 Seikagaku Corp. Exhibit 69: Seikagaku Corp. - Overview Exhibit 70: Seikagaku Corp. - Business segments Exhibit 71: Seikagaku Corp. - Key offerings Exhibit 72: Seikagaku Corp. - Segment focus 10.10 Sun Pharmaceutical Industries Ltd. Exhibit 73: Sun Pharmaceutical Industries Ltd. - Overview Exhibit 74: Sun Pharmaceutical Industries Ltd. - Product and service Exhibit 75: Sun Pharmaceutical Industries Ltd. - Key news Exhibit 76: Sun Pharmaceutical Industries Ltd. - Key offerings 10.11 Teva Pharmaceutical Industries Ltd. Exhibit 77: Teva Pharmaceutical Industries Ltd. - Overview Exhibit 78: Teva Pharmaceutical Industries Ltd. - Business segments Exhibit 79: Teva Pharmaceutical Industries Ltd. - Key offerings Exhibit 80: Teva Pharmaceutical Industries Ltd. - Segment focus 10.12 Viatris Inc. Exhibit 81: Viatris Inc. - Overview Exhibit 82: Viatris Inc. - Business segments Exhibit 83: Viatris Inc. - Key offerings Exhibit 84: Viatris Inc. - Segment focus 11 Appendix 11.1 Scope of the report 11.2 Currency conversion rates for US$ Exhibit 85: Currency conversion rates for US$ 11.3 Research methodology Exhibit 86: Research Methodology Exhibit 87: Validation techniques employed for market sizing Exhibit 88: Information sources 11.4 List of abbreviations Exhibit 89: List of abbreviations About Us Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios. Contact Technavio Research Jesse Maida Media & Marketing Executive US: +1 844 364 1100 UK: +44 203 893 3200 Email: [email protected] Website: SOURCE Technavio

08 Jun 2021

·www.globenewswire.com

Overactive Bladder Pipeline Shows Rapid Advancements in the

Los Angeles, USA, June 07, 2021 (GLOBE NEWSWIRE) -- Overactive Bladder Pipeline Shows Rapid Advancements in the Clinical Trials: A Review by DelveInsight Overactive Bladder therapies with different mechanisms of action are currently being studied with excellent market potential. Ongoing scientific research has provided with greater sophistication and a clearer understanding of the mechanisms of therapeutic interventions, combined with improved outcome measures to assess the efficacy and patient satisfaction, as well as high-quality Overactive Bladder clinical trials with proper design, which would translate into more refined and directed therapies in future years. DelveInsight’s “Overactive Bladder Pipeline Insight” report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in the Overactive Bladder pipeline landscapes. It comprises Overactive Bladder pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Overactive Bladder therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Overactive Bladder pipeline products. Some of the key takeaways from the Overactive Bladder Pipeline Report Get an overview of pipeline landscape @ Overactive Bladder Clinical Trials Analysis Overactive Bladder (OAB) causes a frequent and sudden urge to urinate that may be difficult to control. One may need to pass urine many times during the day and night and may also experience unintentional loss of urine. There are six antimuscarinic agents available for the OAB treatment worldwide- oxybutynin, tolterodine, fesoterodine, trospium, darifenacin, and solifenacin. Overactive Bladder Emerging Drugs Neuronox, an acetylcholine inhibitor is being developed by Medy-Tox for the treatment of the Overactive Bladder. The active ingredients involve Clostridium botulinum toxin type A. It is currently in the phase III stage of development. In September 2020, US drugmaker Allergan entered into a license agreement with South Korea’s Medytox under the terms of which, on closing, Allergan would pay Medytox an upfront of USD 65 million and Medytox would grant Allergan exclusive rights, worldwide outside of Korea, to develop and, if approved, commercialise certain neurotoxin product candidates currently in development, including a potential liquid-injectable product. In May 2020, AbbVie announced that it had finished its acquisition of Allergan plc. following receipt of regulatory approval from all government authorities needed by the transaction agreement and approval by the Irish High Court. Research and DevelopmentPhase III NCT04113941: In August 2019, Medy-Tox initiated a phase III trial, a randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy and safety of Meditoxin in subject with Idiopathic Overactive Bladder. This study is for patients who have idiopathic overactive bladder symptoms. This study will assess the efficacy and safety of Neuronox against placebo. The trial is currently in the active not recruiting stage with an estimated enrollment of 216 participants and anticipated to be completed in August 2021. Urovant Sciences is developing URO-902 for the treatment of the Overactive Bladder. URO-902 has the potential to be the first gene therapy for OAB patients. This innovative treatment has the capability to tackle an unmet need for patients who have failed oral pharmacologic therapies and are concerned with potential urinary retention or surgical interventions pertinent to existing third-line OAB treatments. It is currently in the phase II stage of development. Research and DevelopmentPhase II NCT04211831: In December 2019, Urovant Sciences GmbH initiated a phase II trial titled “An exploratory phase IIa study evaluating the efficacy and safety of URO-902 in subjects with Overactive Bladder and Urge Urinary Incontinence”. This study will investigate the efficacy, safety, and tolerability of a single dose of URO-902 24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up to 48 weeks post-dose. The trial is currently in recruiting stage with an estimated enrollment of 78 participants and expected to be completed in September 2022. Solabegron is a highly potent and selective beta-3 adrenoceptor agonist that is being developed for Overactive Bladder treatment. Solabegron has been tested in over 800 study subjects in a twice-a-day formulation and demonstrated efficacy in treating OAB and Irritable bowel syndrome (IBS). A once-daily formulation designed to optimise patient convenience and effectiveness has been developed and is currently being evaluated in phase 2b dose-ranging clinical trials. Research and DevelopmentPhase II NCT03594058: In July 2018, Velicept Therapeutics initiated a phase IIb, multicenter, randomised, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of oral solabegron modified-release tablets in the treatment of Overactive Bladder in adult female subjects. The trial enrolled 1413 participants and was completed in May 2019. Results Velicept Therapeutics announced that its next-generation beta-3 adrenoceptor agonist solabegron met the primary endpoint in VEL-2002, a phase IIb study in Overactive Bladder patients. In the study, twice-daily administration of solabegron showed a statistically major improvement compared to placebo at week 12, as measured by the mean change in the number of micturitions per day, the study’s primary endpoint. Solabegron also showed statistical significance across various secondary endpoints, comprising a percent reduction of urge urinary incontinence episodes, dry rate, and urgency episodes. For further information, refer to the detailed report @ Overactive Bladder Pipeline Therapeutics Scope of Overactive Bladder Pipeline Drug Insight Key Questions regarding Current Overactive Bladder Treatment Landscape and Emerging Therapies Answered in the Pipeline Report Table of Contents Get a customised pipeline report @ Overactive Bladder Drugs Pipeline Report Related Reports DelveInsight’s Overactive Bladder Market Insights, Epidemiology and Market Forecast report provides a detailed overview of the disease and a depth understanding of historical data. DelveInsight's Overactive Bladder - Epidemiology Forecast 2030 report delivers an in-depth understanding of the disease, historical, and forecasted epidemiology of Overactive Bladder in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. DelveInsight's "Interstitial Lung Disease - Market Insights, Epidemiology, and Market Forecast-2030" report delivers an in-depth understanding of the Interstitial Lung Disease, historical and forecasted epidemiology. DelveInsight's Interstitial Cystitis - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease. DelveInsight's Bronchiolitis Obliterans Syndrome - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. Checkpoint Kinase Inhibitor Pipeline Insights, 2021 report by DelveInsight offers comprehensive insights of the pipeline (under development) therapeutics scenario and growth prospects across Checkpoint Kinase Inhibitor development. Browse ASCO 2021 Abstracts here:- About DelveInsightDelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also provides Healthcare Consulting services comprising credible market analysis that will help accelerate the business growth and overcome challenges with a practical approach.

Gene TherapyCollaborateAcquisitionASCO

06 Dec 2018

·www.globenewswire.com

Veru to Report Fiscal Year 2018 Financial Results, Host Conference Call on December 13th

MIAMI, Dec. 06, 2018 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company, today announced that on Thursday, December 13, 2018, the company will report financial results for the fourth quarter and fiscal year ended September 30, 2018, before the market opens. Veru management will host a conference call that same day at 8 a.m. Eastern Time to review the company’s performance and to answer questions. Event DetailsInterested investors may access the call by dialing 800-341-1602 from the U.S. or 412-902-6706 from outside the U.S. and asking to be joined into the Veru Inc. call. In addition, investors may access a replay of the conference call the same day beginning at approximately noon Eastern Time by dialing 877-344-7529 for US callers, or 412-317-0088 from outside the U.S., passcode 10126693. The replay will be available for one week, after which, the recording will be available via the company’s website at https://verupharma.com/investors. About Veru Inc.Veru Inc. is an oncology and urology biopharmaceutical company developing novel medicines for prostate cancer and prostate cancer supportive care as well as near term specialty pharmaceuticals to address significant unmet needs in urology. The Veru prostate cancer pipeline includes zuclomiphene citrate (also known as VERU-944, cis-clomiphene) and VERU-111 (bisindole). Zuclomiphene citrate is an estrogen receptor agonist being evaluated in a Phase 2 trial to treat hot flashes, a common side effect caused by hormone treatment for men with advanced prostate cancer. VERU-111 is an oral, next-generation, first-in-class small molecule that targets and binds to alpha and beta subunits of microtubules in cells to treat metastatic prostate cancer patients whose disease is resistant to both castration and novel androgen blocking agent (abiraterone or enzalutamide) therapies. Veru expects VERU-111 to enter a Phase 1b/2 clinical trial in late 2018. Veru is also advancing four new drug formulations in its specialty pharmaceutical pipeline addressing unmet medical needs in urology. Tamsulosin DRS granules and Tamsulosin XR capsules are formulations of tamsulosin, the active ingredient in FLOMAX®, which Veru has developed to avoid the “food effect” inherent in currently marketed formulations of this drug, allowing for potentially safer administration and improved patient compliance (NDA submission expected in 2019). Veru is also developing Tadalafil/Finasteride combination tablets for inhibition of both phosphodiesterase type 5 (PDE5) and 5-alpha-reductase to shrink an enlarged prostate, treat symptoms of BPH and to treat erectile dysfunction (NDA submission expected in 2019). Finally, Veru is developing Solifenacin DRG granules, a formulation of a selective M3 muscarinic receptor antagonist for the treatment of overactive bladder in patients who have difficulty with swallowing tablets (NDA submission expected in 2019). Veru’s currently marketed products are the PREBOOST® medicated individual wipe for the prevention of premature ejaculation and the FC2 Female Condom®. The Female Health Company Division markets the FC2 Female Condom® in the global public health sector to improve the lives, health and well-being of women around the world. To learn more please visit www.verupharma.com. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:The statements in this release that are not historical facts are "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements relating to the regulatory pathway to secure FDA approval of the Company's drug candidates and the anticipated timeframe for clinical studies and FDA submissions. Any forward-looking statements in this release are based upon the Company's current plans and strategies and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this release. The Company assumes no obligation to update any forward-looking statements contained in this release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, the following: risks related to the development of the Company's product portfolio, including clinical trials, regulatory approvals and time and cost to bring to market; potential delays in the timing of and results from clinical trials and studies and the risk that such results will not support marketing approval and commercialization; potential delays in the timing of any submission to the FDA and regulatory approval of products under development; risks relating to the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; product demand and market acceptance; competition in the Company's markets and the risk of new or existing competitors with greater resources and capabilities and new competitive product introductions; price erosion, both from competing products and increased government pricing pressures; manufacturing and quality control problems; compliance and regulatory matters, including costs and delays resulting from extensive governmental regulation, and effects of healthcare insurance and regulation, including reductions in reimbursement and coverage or reclassification of products; some of the Company's products are in development and the Company may fail to successfully commercialize such products; risks related to intellectual property, including the uncertainty of obtaining patents, the effectiveness of the patents or other intellectual property protections and ability to enforce them against third parties, the uncertainty regarding patent coverages, the possibility of infringing a third party’s patents or other intellectual property rights, and licensing risks; government contracting risks, including the appropriations process and funding priorities, potential bureaucratic delays in awarding contracts, process errors, politics or other pressures, and the risk that government tenders and contracts may be subject to cancellation, delay, restructuring or substantial delayed payments; a governmental tender award indicates acceptance of the bidder's price rather than an order or guarantee of the purchase of any minimum number of units, and as a result government ministries or other public sector customers may order and purchase fewer units than the full maximum tender amount or award; penalties and/or debarment for failure to satisfy tender awards; the Company's reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; risks related to concentration of accounts receivable with our largest customers and the collection of those receivables; the economic and business environment and the impact of government pressures; risks involved in doing business on an international level, including currency risks, regulatory requirements, political risks, export restrictions and other trade barriers; the Company's production capacity, efficiency and supply constraints and interruptions, including due to labor unrest or strikes; risks related to the costs and other effects of litigation, including product liability claims; the Company's ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company's ability to successfully integrate acquired businesses, technologies or products; and other risks detailed in the Company's press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2017. These documents are available on the "SEC Filings" section of our website at www.verupharma.com/investors. Contact:Kevin Gilbert 786-322-2213

Financial StatementFirst in ClassSmall molecular drugAcquisition

100 Deals associated with Solifenacin Succinate

External Link

KEGG	Wiki	ATC	Drug Bank
D01269	Solifenacin Succinate	G04BD08	DB01591

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Neurogenic detrusor overactivity	US	Astellas Pharma US, Inc.	26 May 2020
Urinary Bladder, Overactive	JP	Astellas Pharma, Inc.	20 Apr 2006
Pollakisuria	US	Astellas Pharma US, Inc.	19 Nov 2004
Urinary Incontinence, Urge	US	Astellas Pharma US, Inc.	19 Nov 2004

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Urinary Bladder, Overactive	Phase 2	IT	Astellas Pharma, Inc.	01 Jul 2003
Urinary Bladder, Overactive	Phase 2	RU	Astellas Pharma, Inc.	01 Jul 2003
Urinary Bladder, Overactive	Phase 2	UA	Astellas Pharma, Inc.	01 Jul 2003
Urinary Bladder, Overactive	Phase 2	SK	Astellas Pharma, Inc.	01 Jul 2003
Urinary Bladder, Overactive	Phase 2	NO	Astellas Pharma, Inc.	01 Jul 2003
Urinary Bladder, Overactive	Phase 2	DE	Astellas Pharma, Inc.	01 Jul 2003
Urinary Bladder, Overactive	Phase 2	BE	Astellas Pharma, Inc.	01 Jul 2003
Urinary Bladder, Overactive	Phase 2	DK	Astellas Pharma, Inc.	01 Jul 2003
Urinary Bladder, Overactive	Phase 2	CZ	Astellas Pharma, Inc.	01 Jul 2003
Urinary Bladder, Overactive	Phase 2	GB	Astellas Pharma, Inc.	01 Jul 2003

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03149809 (BOSS PD, CTgov)	Phase 3	Urinary Bladder, Overactive \| Parkinson Disease	77	Pelvic floor muscle exercise-based behavioral therapy (Behavioral Therapy)	pxaueddzxr(otdbthncex) = slmxhtjnfl czfhzgigfs (jtorwlcslr, laierzsnma - ijbhykdpfy) View more	-	24 Sep 2024
				solifenacin (Drug Therapy)	pxaueddzxr(otdbthncex) = iqdlhvocoh czfhzgigfs (jtorwlcslr, vwuhtakqbc - gkuyshoydy) View more
NCT01565694 (CTgov)	Phase 3	Neurogenic detrusor overactivity	76	Solifenacin succinate	ptzgvcnqvp(ktvcetpfjp) = kgkhvqnzve anosvydlkx (ehpdeduify, wdtmoythtf - vpshsmuyqp) View more	-	06 May 2019
NCT02549196 (CPC-12, CTgov)	Phase 2	Dystocia \| Dementia due to Alzheimer's disease (disorder)	28	Donepezil+Solifenacin (Cohort 1)	pfmlixkhpl(dsjzhwuhfz) = dwwcczgggg hjbfwyfqxc (vzwhjfxgip, opetjjhcff - ghqpknbwxw) View more	-	05 Mar 2019
				Donepezil+Solifenacin (Cohort 2)	pfmlixkhpl(dsjzhwuhfz) = gjbedepnof hjbfwyfqxc (vzwhjfxgip, ohghrbwzhu - ksedleonyh) View more
NCT02294396 (CTgov)	Phase 4	Urinary Bladder, Overactive	649	Mirabegron tablet+Solifenacin tablet (Mirabegron + Solifenacin)	fsjwxbjwsv(ciypxtxlno) = pzahwozgkh yscxgepvpd (ikabutddob, iqolevploe - obgtrqqoqs) View more	-	24 Dec 2018
				Mirabegron tablet+Propiverine tablet (Mirabegron + Propiverine)	fsjwxbjwsv(ciypxtxlno) = snowbjrmbg yscxgepvpd (ikabutddob, oqhfvqumns - lfuualligl) View more
NCT01981954 (CTgov)	Phase 3	Neurogenic detrusor overactivity	23	Solifenacin succinate	ihleabdcou(ifubcmknji) = yfubnwolkl epzsofdbvn (pcfsaplhty, urytelqehf - edpqtcljpe) View more	-	21 Jun 2018
NCT01972841 (SYNERGY, CTgov)	Phase 3	Urinary Bladder, Overactive	3,527	placebo (Placebo)	jupxoxuihy(luvvyxaqza) = zvpazjyzzy ydbwvlpdjy (hhlnemywuq, jneznnupyi - cjkyhcetwp) View more	-	12 Jun 2018
				Mirabegron (Mirabegron 25 mg)	jupxoxuihy(luvvyxaqza) = zsgbestnuh ydbwvlpdjy (hhlnemywuq, rszcyswubv - clqrtewysw) View more
NCT02045862 (SYNERGY II, CTgov)	Phase 3	Urinary Bladder, Overactive	1,829	Placebo to match solifenacin+Mirabegron (Mirabegron 50 mg)	xvxmjwvsts(okdejhokdx) = qjfvwmxoqf cdciybvsuv (shmwzwchtv, vdatauwjij - wfvcyiedsv) View more	-	06 Jun 2018
				Placebo to match mirabegron+Solifenacin succinate (Solifenacin 5 mg)	xvxmjwvsts(okdejhokdx) = dzuppyrprf cdciybvsuv (shmwzwchtv, jesqwkknqh - zlhxjyqqsl) View more
NCT01745094 (CTgov)	Phase 4	Urinary Bladder, Overactive	223	Mirabegron+Solifenacin (Solifenacin 2.5 mg + Mirabegron 25 mg)	kzwwxvjxlt(owcxgtxcqp) = dirypdgvxn srtlvnayex (apnzujjzpu, lbpucphzps - sdpcyixisw) View more	-	28 Feb 2018
				Mirabegron+Solifenacin (Solifenacin 2.5 mg + Mirabegron 50 mg)	kzwwxvjxlt(owcxgtxcqp) = yaeogwxwuo srtlvnayex (apnzujjzpu, oiwtyuozef - nuxrihtuxg) View more
NCT01908829 (BESIDE, CTgov)	Phase 3	Urinary Incontinence \| Overactive bladder syndrome	2,174	solifenacin 10 mg matching placebo+mirabegron 25 mg+solifenacin 5 mg (Combination (Solifenacin + Mirabegron))	aavyjgoqhn(ohwrqfokev) = hgdlneduyn jtqofqfbcq (ytjxzpazdt, tzgtrkftbh - jsjhlumrip) View more	-	09 Oct 2017
				mirabegron 25 mg matching placebo+solifenacin 5 mg (Solifenacin 5 mg)	aavyjgoqhn(ohwrqfokev) = goiclvoizn jtqofqfbcq (ytjxzpazdt, rxnqobnulp - cnpeyqihcs) View more

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